Tranexamic Acid
- Product NDC
- 70771-1989
- 11-digit product format
- 707711989
- Labeler code
- 70771
- Product ID
- 70771-1989_51633175-a071-4fe7-bb98-e4743cf19d10
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tranexamic Acid
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Zydus Lifesciences Limited
- Application
- ANDA221213
- Marketing category
- ANDA
- Marketing start
- 2026-11-01
- Substance
- TRANEXAMIC ACID
- Active strength
- 650 mg/1
- Pharmacologic classes
- Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Source provenance: Browse the complete Orange Book source catalog.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tranexamic Acid
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TRANEXAMIC ACID | 650 mg/1 |
Harmonized UNII identifiers#
UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table| Identifier | FDA.report destination |
|---|
| 6T84R30KC1 | Internal UNII lookup |
Harmonized SPL set identifiers#
SPL set identifiers page 1 of 1 · 1 matching rows.
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70771-1989-3 | 70771198903 | 30 TABLET in 1 BOTTLE (70771-1989-3) | 30 tablet | 2026-11-01 | No | No | Current |